FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956416079
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PN11SF36D
Catalog number
PN11SF36D
Device description
KIT, THORACOLUMBAR FUSION
Published
2026-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956416077PackageGS11In Commercial Distribution
10198956416079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895641607750198956416077
1019895641607910198956416079

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, medicatedA collection of various sterile neurosurgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform a neurosurgical procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06
10198956428881CARDINAL HEALTHSOP45HPKPISOP45HPKPI2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956502062CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956515536CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956524873CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956525344CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956527348CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956336865CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956475106CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956476301CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956490284CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956496064CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956497610CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956498273CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956501737CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956503496CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-08
10198956332522CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956400726CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956429604CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956450486CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956457416CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956460591CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956472167CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956483071CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956486089CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956492516CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956493193CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956495111CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956495487CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956495975CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10198956498280CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-05
10809160522561HalyardAVID MEDICAL, INC.OJG2026-06-04